Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PCO Manufacturing
1 Milligram
Tablets
2001-10-05
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Detrusitol 1 mg Film-coated Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg tolterodine tartrate equivalent to 0.68 mg tolterodine. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Round, white tablets with ‘TO’ and arcs above and below the lettering on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ADULTS (INCLUDING THE ELDERLY):_ The recommended dose is 2 mg twice daily except in patients with impaired liver function or severely impaired renal function (GFR ≤ 30ml/min) for whom the recommended dose is 1mg twice daily (see section 4.4) . In case of troublesome side-effects the dose may be reduced from 2 mg to 1 mg twice daily. The effect of treatment should be re-evaluated after 2-3 months (see section 5.1). _Paediatric Patients:_ Efficacy of Detrusitol has not been demonstrated in children (See section 5.1). Therefore, Detrusitol is not recommended for children_._ 4.3 CONTRAINDICATIONS Tolterodine is contra-indicated in patients with: o urinary retention, o uncontrolled narrow angle glaucoma, o myasthenia gravis, o known hypersensitivity to tolterodine or excipients, o severe ulcerative colitis, o toxic megacolon. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Tolterodine should be used with caution in patients with: significant bladder outlet obstruction at risk of urinary retention, gastrointestinal obstructive disorders e.g. pyloric stenosis, IRISH MEDICINES BOARD _____________________________________________________________________ Read the complete document